Question
At the beginning of 2015 I wrote a blog about 510(k) project management (http://medicaldeviceacademy.com/510k-project-management-an-inside-look-at-our-process/) and I recorded a webinar on the topic (http://medicaldeviceacademy.com/510k-project-manag...
When I worked at medical centers as a Medical Technologist, years ago, we commonly drew blood from branch lines of catheters. So, not much new here. I looked up the patent application (US20160051174 - https://www.google.com/patents/US20160051174?dq=i...
Hello all,Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC.The Situation is, the harmonized standard EN 60601-1:2006/A...
Hello everyone, I am evaluating the incorporation of remote data logging and network (likely wireless) connectivity for a class II and potentially class III device. Could anyone point me in the direction of any 510k cleared predicate devices that I m...
Design, addresses the topic in a thoughtful and engaging manner. http://ow.ly/Ie2o302FZrkColor In Medical ProductsThe delivery of health care is evolving to take into account the entire patient experience. Medical products and devices have a signific...
I'm largely ignorant of how Class I devices get on the market and then what happens next. I typically work with Class III, and sometimes Class II. However, I've started running into early-phase start-ups with a basic technology that could be develope...
Medical devices sold in Europe carry the CE Mark. Does anyone have a list of non-EU countries who also require the CE Mark? (e.g. the Saudi regulatory body will accept the mark)Thanks for your feedback!source: https://www.linkedin.com/groups/78665/78...
Do you believe it's worthwhile to market a medical device used in surgery directly to patients? I don't. To be clear, I'm not talking about durable medical equipment (wheelchairs, diabetic supplies). I'm talking about devices that "improve patient ou...
One issue I always had during my career was the unknown condition of equipment that had been used around patients and possible exposed to bodily fluids. I was worried about whether they could present a bio-hazard to repair and indeed the entire organ...
Many available sources of light therapy will deter the degeneration of Alzheimer's and TBI, non-invasively. However, until someone large enough to afford FDA approval undertakes the initiative, the tragic onslaught of dementia will continue. This vid...
